Ayahuasca Assisted Psychotherapy for Grief

NCT ID: NCT06150859

Last Updated: 2023-12-11

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE2
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-15
• Study Completion Date: 2024-06-15

Brief Summary

The aim of this study is to compare the effectiveness of an ayahuasca-assisted constructivist therapy with constructivist therapy and no treatment to decrease the severity of grief. A secondary purpose is to assess the effectiveness to prevent Persistent Complex Bereavement Disorder and Prolonged Grief Disorder, and to assess potential changes in avoidance, meaning-making and self-clarity. Subjective effects and Acceptance promoting effects of psychedelic drug are assessed after ayahuasca administration. A non-randomized controlled trial is proposed with three arms involving an experimental group (ayahuasca in concert with psychotherapy) and two control groups (psychotherapy and no treatment) with pretest, posttest and 3 months follow-up.

Detailed Description

Grief is a deep and intense sorrow caused by the loss of someone loved. Although every person could benefit from support, only a substantial minority of bereaved people experience severe, persistent and disabling grief (PCBD), requiring treatment one year after the death of a loved one. However, pharmacotherapy alone has not proven to be effective, and while psychological interventions for prolonged grief disorder may be efficacious, the clinical effectiveness is small (Hedges' g: 0.41-0.45). As far as we know, no bereavement prevention program has proven to be effective, and early interventions are discouraged. Thus, there are no effective resources for supporting the bereaved during the months following the death of a loved one, a need which peaks during the months following the death, when grief is most intense and the bereaved lives are at their highest level of risk.

Conditions

Bereavement

Keywords

Bereavement; Ayahuasca; Psychotherapy; Prevention

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Experimental: Ayahuasca-assisted constructivist therapy.

Constructivist psychotherapy will be delivered over 9 online psychotherapeutic sessions interconnected in 3 modules to process trauma, restore attachment security and reconstruct the self. One preparation session and two integration sessions after two ayahuasca administrations are included to the experimental group.

Group Type: EXPERIMENTAL

Ayahausca-Assisted psychotherapy

Intervention Type: DRUG

Drug: Two ayahuasca administrations (0.75 mg/kg DMT), after 3rd and 6th therapeutic session. Ayahuasca is a psychoactive mixture of plants which contains DMT as an active principle.

Constructivist Psychotherapy will be delivered over 9 online psychotherapeutic sessions.

Constructivist Psychotherapy

Constructivist Psychotherapy will be delivered over 9 online psychotherapeutic sessions interconnected in 3 modules to process trauma, restore attachment security and reconstruct the self.

Once the follow-up period is over (3 months), participants have the option of receiving 2 administrations of ayahuasca if the severity of grief is high.

Group Type: ACTIVE_COMPARATOR

Constructivist Psychotherapy

Intervention Type: BEHAVIORAL

Constructivist Psychotherapy will be delivered over 9 online psychotherapeutic sessions

No treatment

Participants received no treatment during the 9-week Control Period.

Once the follow-up period is over (3 months), participants have the option of receiving 2 administrations of ayahuasca if the severity of grief is high.

Group Type: OTHER

No treatment

Intervention Type: OTHER

No treatment during the control period

Interventions

Ayahausca-Assisted psychotherapy

Drug: Two ayahuasca administrations (0.75 mg/kg DMT), after 3rd and 6th therapeutic session. Ayahuasca is a psychoactive mixture of plants which contains DMT as an active principle.

Constructivist Psychotherapy will be delivered over 9 online psychotherapeutic sessions.

Intervention Type: DRUG

Constructivist Psychotherapy

Constructivist Psychotherapy will be delivered over 9 online psychotherapeutic sessions

Intervention Type: BEHAVIORAL

No treatment

No treatment during the control period

Intervention Type: OTHER

Other Intervention Names

Ayahausca-assisted grief therapy

Eligibility Criteria

Inclusion Criteria

• Experienced the loss of a first- degree relative not more than 12 months prior to enrollment as indicated by self-report.
• Scores up to 40 in the Texas Revised Inventory of Grief (TRIG).

Exclusion Criteria

• Pregnant or breastfeeding women.
• Hypertension (systolic blood pressure above 140 mm, diastolic above 90 mm and heart rate above 100 bpm).
• History of psychotic disorder (Axis I-II of the DSM-V).
• Substance use disorder (except nicotine).
• Alcohol consumption greater than 40 g/day.
• Receiving psychological or self-help therapy during the study on a regular basis.
• Receiving regular pharmacological therapy for complicated grief during the study.
• Regular intake of any type of medication in the month preceding the study.
• Treatment with single doses of symptomatic medication during the study may be accepted (as long as it can be assumed that the ingested drug has been completely eliminated on the days of the ayahuasca administrations).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beckley Med Foundation

OTHER

Sponsor Role: lead

Responsible Party

Débora González

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Magi Farré

Role: STUDY_DIRECTOR

Hospital German Trials I Pujol

Locations

Institut de Recerca Holistica de Montserat (Irehom)

Barcelona, , Spain

Countries

Spain

References

Sabucedo P, Andion O, Neimeyer RA, Soto-Angona O, Javkin J, Haro JM, Farre M, Gonzalez D. Ayahuasca-assisted meaning reconstruction therapy for grief: a non-randomized clinical trial protocol. Front Psychiatry. 2025 Jan 7;15:1484736. doi: 10.3389/fpsyt.2024.1484736. eCollection 2024.

Reference Type: DERIVED

PMID: 39839135 (View on PubMed)

Other Identifiers

PI-19-118

Identifier Type: -

Identifier Source: org_study_id